DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 19 March 2026 has been entered.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-5, 7-18, and 20-23 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 1, the phrase “generate spectral feature information from the received EEG data by analyzing the received EEG data to determine spectral edge frequency (SEF) information” renders the claim indefinite. As currently written, the phrase incorporates both a broad limitation (spectral feature information) and a narrow limitation (spectral edge frequency information). A broad recitation along with a narrower limitation within the same claim renders the claim indefinite. Furthermore, the phrase makes it unclear as to whether or not the “the spectral feature information” in the phrase “develop a treatment plan based on the spectral feature information” is referring to the broader, generated “spectral feature information” or to the narrower, determined “spectral edge frequency (SEF) information”. For this examination, the determined spectral edge frequency information is being considered the spectra feature information. The same indefiniteness issue and interpretation apply to claim 12.
Regarding claim 21, the phrase “the evoked somatosensory stimulation epochs” lacks proper antecedent basis. For this examination, the phrase is being interpreted as “the somatosensory stimulation epochs”.
Claims not explicitly rejected above are rejected due to their dependence on a rejected base claim.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-5 are rejected under 35 U.S.C. 103 as being unpatentable over O’Reilly et al. (Peak-to-peak amplitude in neonatal brain monitoring in premature infants – previously cited) in view of Inder et al. (Lowered Electroencephalographic Spectral Edge Frequency Predicts the Presence of Cerebral White Matter Injury in Premature Infants – previously cited) further in view of Bell’462 (US Pub No. 2009/0018462 – previously cited) further in view of Barlow et al.’814 (US Pub No. 2006/0079814 – previously cited).
Regarding claims 1 and 2, O’Reilly et al. discloses a neural analysis and treatment system for monitoring preterm (premature) infants, the system comprising: a computing device having at least one processor and at least one computer-readable medium, the at least one computer-readable medium including instructions executable by the at least one processor (the method described in the 2. Methods section on page 2141 inherently requires the use of a system comprising at least one processor and at least one computer-readable medium including instructions executable by the at least processor); and one or more electrodes configured to measure electroencephalography (EEG) data of a patient (page 2141, section 2.2. EEG and aEEG recording); wherein the instructions, when executed by the at least one processor, cause the at least one processor to: receive EEG data of the patient from the one or more electrodes, wherein the EEG data includes raw EEG data, amplitude-integrated EEG (aEEG) data, range EEG (r-EEG) data, or a combination thereof (ABSTRACT, 2. Methods section), and generate information from the received diagnostic EEG data, the diagnostic information being used to determine neonatal brain maturation (ABSTRACT, 2. Methods section, 3. Results section, and first four paragraphs of 4. Discussion section).
O’Reilly et al. discloses all of the elements of the current invention, as discussed above, except for the generated information being spectral edge frequency (SEF) information. Inder et al. teaches that SEF-based measurements derived from received EEG data are useful for defining the presence and severity of white matter injury in preterm infants (see Conclusions). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the system of O'Reilly et al. to include a processor configured to determine an SEF measurement from the received EEG data, as taught by Inder et al., since it would be useful for defining the presence and severity of white matter injury in the preterm infants.
It is noted that O’Reilly et al. discloses that its one or more electrodes receive EEG data continuously for 72 hours after the infant’s birth (page 2141, section 2.2. EEG and aEEG recording, second paragraph). When the infant is being fed, the spectral feature information that is generated is generated from the EEG data acquired during somatosensory stimulation epochs and characterizes thalamocortical excitation evoked by synchronous volleys of oral mechanoreceptive afferent activity of a trigeminal nerve. Furthermore, Claim 1 is drawn to a system; the processor of the system is capable of performing its functions at any time, including during somatosensory stimulation epochs characterizing thalamocortical excitation evoked by synchronous volleys of oral mechanoreceptive afferent activity of a trigeminal nerve.
O’Reilly et al. in view of Inder et al. discloses all of the elements of the current invention, as discussed above, except for developing a treatment plan based on the spectral feature information. Bell’462 teaches developing one or more treatment plans based upon a neural characteristic of a patient in order to provide an appropriate therapeutic response to the patient (page 5, section [0052]). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the system of O’Reilly et al. further in view of Inder et al. to include a processor configured to develop one or more treatment plans based upon the spectral feature information, since Bell’462 teaches that it would allow a proper therapy to be provided to the preterm infant based on the determined neural condition of the preterm infant.
O’Reilly et al. in view of Inder et al. further in view of Bell'462 discloses all of the elements of the current invention, as discussed above, except for the treatment plan entraining electrophysiological development in a brain of the patient. Barlow et al.’814 teaches that an appropriate treatment plan for premature infants includes the use of a closed-loop non-nutritive suck entrainment stimulus device, the stimulus device comprising a somatosensory stimulus device comprising a pneumatically-charged device (see TITLE, ABSTRACT, SUMMARY, and sections [0009-0010], [0012], [0026], [0031], [0042], and [0045]). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed for the treatment plan of O’Reilly et al. in view of Inder et al. further in view of Bell'462 to include use of the closed-loop non-nutritive suck entrainment stimulus device and method taught by Barlow et al.’814, since Barlow et al.’814 teaches that its device and method are an appropriate treatment plan for preterm infants. The treatment plan disclosed by Barlow et al.’814 entrains electrophysiological development in the brain of the preterm infant (which means that it alters cortical activity and/or promotes cortical adaptation of the preterm infant). In combination with O’Reilly et al. in view of Inder et al. further in view of Bell’462, the treatment plan would be based on the generated spectral feature information obtained from the received EEG data that is received from the one or more electrodes.
The closed-loop non-nutritive suck entrainment stimulus device of O’Reilly et al. in view of Inder et al. further in view of Bell’462 further in view of Barlow et al.’814 is a somatosensory stimulus device configured to provide additional somatosensory stimuli to the patient. In the combination of O’Reilly et al. in view of Inder et al. further in view of Bell’462 further in view of Barlow et al.’814, the at least one processor is configured to generate one or more control signals to the somatosensory stimulus device to provide somatosensory stimuli to the patient, wherein the one or more control signals are generated in response to the EEG data received from the one or more electrodes.
Regarding claim 3, changes in the SEF measurements of O’Reilly et al. in view of Inder et al. further in view of Bell’462 further in view of Barlow et al.’814 are monitored in order to allow the system to monitor the effect of the treatment on the patient. Changes in the SEF measurements are an SEF modulation of the EEG spectra of the received EEG spectra.
Regarding claims 4 and 5, by virtue of entraining electrophysiological development in the brain of the patient with the same type of somatosensory stimulus device as that of the claimed invention, the system of O’Reilly et al. in view of Inder et al. further in view of Bell’462 further in view of Barlow et al.’814 entrains neurostructural development in the patient’s brain, wherein the neurostructural development in the brain of the patient includes development of cortical connections in the brain of the patient.
Claims 7-11, 21, and 22 are rejected under 35 U.S.C. 103 as being unpatentable over O’Reilly et al. in view of Inder et al. further in view of Bell’462 further in view of Barlow et al.’814, as applied to claim 1, further in view of Shahaf et al.’569 (US Pub No. 2012/0296569 – previously cited).
Regarding claim 7, O’Reilly et al. in view of Inder et al. further in view of Bell’462 further in view of Barlow et al.’814 discloses all of the elements of the current invention, as discussed in paragraph 6 above, except for the at least one processor being configured to receive EEG data from the patient prior to, during, and after generating the control signal. Shahaf et al.’569 teaches receiving diagnostic information from a patient before, during, and after providing treatment to the patient. Shahaf et al.’569 receives the diagnostic information before, during, and after providing treatment in order to assess the effect of the treatment on the patient (sections [0047] and [0259]). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the system of O’Reilly et al. in view of Inder et al. further in view of Bell’462 further in view of Barlow et al.’814 to include configuring its at least one processor to receive the EEG data of the patient from the one or more electrodes prior to, during, and after generating the control signal since Shahaf et al.’569 teaches that this would allow the system to monitor the effect of the treatment on the patient.
In the combination of O’Reilly et al. in view of Inder et al. further in view of Bell’462 further in view of Barlow et al.’814 further in view of Shahaf et al.’569, the at least one processor is configured to generate a control signal to the somatosensory stimulus device to perform the generated treatment plan (as taught by Barlow et al.’814), wherein EEG data is received before, during, and after the treatment is provided in order to determine the effectiveness of the treatment (as taught by Shahaf et al.’569). This would include receiving post-treatment EEG data of the patient from the one or more electrodes after the treatment plan has been performed, generating post-treatment spectral feature information from the received post-treatment EEG data (as taught by Inder et al.), and determining an electrophysiological development level of the brain of the patient using the spectral feature information and the post-treatment spectral feature information (O’Reilly et al. in view of Inder et al. already determines a brain development level (brain maturation) of the patient according to the original spectral feature information, and when modified by Shahaf et al.’569, the system would determine the brain development level according to all of the available spectral feature information).
Regarding claim 8, as noted above with respect to claim 1, the post-treatment EEG data would include raw EEG data, amplitude-integrated EEG (aEEG) data, range EEG (r-EEG) data, or a combination thereof.
Regarding claim 9, as noted above with respect to claim 3, the post-treatment spectral feature information would include SEF modulation information of the EEG spectra of the received EEG data.
Regarding claims 10, 11, and 22, the electrophysiology development level of the brain comprises a quantified cortical activity and a quantified cortical adaptation of the patient (any of the quantified SEF, aEEG, rEEG measurements, and any of the quantified changes of the measurements after each treatment session). The electrophysiology development level of the brain/quantified cortical activity/quantified cortical adapation is a characterization of persistent spectral modulation in one or more post-stimulation epochs following the somatosensory stimulation epochs, wherein the persistent spectral modulation is indicative of cortical adaptation of the patient.
Regarding claim 21, as EEG data is received during the applied somatosensory stimuli treatment, the spectral feature information generated from the EEG data is generated from the synchronous volleys of oral mechanoreceptive afferent activity in maxillary and mandibular divisions of the trigeminal nerve, the generated spectral feature information being generated during the evoked somatosensory stimulation epochs.
Claims 12-18, 20, and 23 are rejected under 35 U.S.C. 103 as being unpatentable over O’Reilly et al. in view of Inder et al. further in view of Bell’462 further in view of Barlow et al.’814 further in view of Shahaf et al.’569.
Regarding claims 12-18 and 20, the sections of O’Reilly et al. cited in paragraphs 6 and 7 above, as modified by Inder et al., Bell’462, Barlow et al.’814, and Shahaf et al.’569, disclose a method comprising the steps recited in the claims.
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over O’Reilly et al. in view of Inder et al. further in view of Bell’462 further in view of Barlow et al.’814, as applied to claim 1, further in view of Shahaf et al.’569 further in view of Niemarkt et al. (Maturational Changes in Automated EEG Spectral Power Analysis in Preterm Infants – previously cited).
This rejection is being provided as an alternative to the rejection of claim 22 presented in paragraph 7 above.
O’Reilly et al. in view of Inder et al. further in view of Bell’462 further in view of Barlow et al.’814 further in view of Shahaf et al.’569 discloses all of the elements of the current invention, as discussed in paragraph 7 above, except for the at least one processor being further configured to characterize persistent spectral modulation in one or more post-stimulation epochs following the somatosensory stimulation epochs, wherein the persistent spectral modulation is indicative of cortical adaptation of the patient. Niemarkt et al. teaches that using at least one processor to analyze changes (a modulation) in an SEF measurement is useful for brain monitoring in preterm infants and for indicating functional cerebral maturation (page 529, right column, last sentence beginning with “West et al. (17)…” – page 530, left column, line 7). The entirety of the DISCUSSION section of Niemarkt et al. discusses characterizing persistent spectral modulation in a preterm infant, wherein the characterization is an indication of cortical adaptation of the preterm infant. It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the at least one processor of O’Reilly et al. in view of Inder et al. further in view of Bell’462 further in view of Barlow et al.’814 further in view of Shahaf et al.’569 to be configured to characterize persistent spectral modulation in one or more post-stimulation epochs following the somatosensory stimulation epochs, as this would provide an assessment of the patient’s cortical adaptation before, during, and after treatment.
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over O’Reilly et al. in view of Inder et al. further in view of Bell’462 further in view of Barlow et al.’814 further in view of Shahaf et al.’569, as applied to claim 12, further in view of Niemarkt et al.
This rejection is being provided as an alternative to the rejection of claim 23 presented in paragraph 7/8 above.
O’Reilly et al. in view of Inder et al. further in view of Bell’462 further in view of Barlow et al.’814 further in view of Shahaf et al.’569 discloses all of the elements of the current invention, as discussed in paragraph 8 above, except characterizing, via the computing device, persistent spectral modulation in one or more post-stimulation epochs following the somatosensory stimulation epochs, wherein the persistent spectral modulation is indicative of cortical adaptation of the patient. Niemarkt et al. teaches that using a computing device to analyze changes (a modulation) in an SEF measurement is useful for brain monitoring in preterm infants and for indicating functional cerebral maturation (page 529, right column, last sentence beginning with “West et al. (17)…” – page 530, left column, line 7). The entirety of the DISCUSSION section of Niemarkt et al. discusses characterizing persistent spectral modulation in a preterm infant, wherein the characterization is an indication of cortical adaptation of the preterm infant. It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the method of O’Reilly et al. in view of Inder et al. further in view of Bell’462 further in view of Barlow et al.’814 further in view of Shahaf et al.’569 to include characterizing persistent spectral modulation in one or more post-stimulation epochs following the somatosensory stimulation epochs, as this would provide an assessment of the patient’s cortical adaptation before, during, and after treatment.
Response to Arguments
Applicant's arguments filed 19 March 2026 have been fully considered and are not persuasive.
The Examiner maintains that the limitation “wherein the spectral feature information is generated from the EEG data acquired during somatosensory stimulation epochs and characterizing thalamocortical excitation evoked by synchronous volleys of oral mechanoreceptive afferent activity of a trigeminal nerve” in claim 1 is taught by the cited prior art. The limitation only requires the claimed neural analysis and treatment system be capable of acquiring EEG data during somatosensory stimulation epochs, wherein the EEG data would characterize whatever neural activity is being experienced by a patient. The system of O’Reilly in view of Inder further in view of Bell further in view of Barlow is capable of being used while a patient is subjected to somatosensory stimulation that causes thalamocortical excitation evoked by synchronous volleys of oral mechanoreceptive afferent activity of a trigeminal nerve (e.g., feeding that requires a sucking motion). If thalamocortical excitation evoked by synchronous volleys of mechanoreceptive afferent activity of a trigeminal nerve is being experienced by the patient, then the EEG data acquired by the neural analysis and treatment system of the cited prior art would characterize that neural activity.
Contrary to Applicant’s assertion that the “capable of” reasoning improperly disregards the structural and functional requirements of amended independent claim 1, each structural and functional requirement required by claim 1 is met by the cited prior art. The prior art device taught by O’Reilly in view of Inder further in view of Bell further in view of Barlow possesses the structure necessary to perform the particular functions recited in claim 1. As modified by Inder, the device of O’Reilly receives EEG data to determine spectral edge frequency information. That EEG data can be obtained while the patient is subjected to somatosensory stimulation epochs that trigger thalamocortical excitation evoked by synchronous volleys of oral mechanoreceptive afferent activity of a trigeminal nerve.
Applicant argues that the Examiner’s reasoning that “when the infant is being fed, the spectral feature information that is generated is generated from the EEG data acquired during somatosensory stimulation epochs and characterizes thalamocortical excitation evoked by synchronous volleys of oral mechanoreceptive afferent activity of a trigeminal nerve” conflates incidental oral activity during feeding with the specific, controlled, patterned oral somatosensory stimulation delivered by a pneumatically-charged device as recited in amended independent claim 1. This argument is not persuasive as claim 1 does not recite acquiring the EEG data during specific, controlled, patterned oral somatosensory stimulation delivered by a pneumatically-charged device. It is noted that as the claim is currently written, the “somatosensory stimulation epochs” of the phrase “from the EEG data acquired during somatosensory stimulation epochs” need not be the “somatosensory stimuli” provided by the somatosensory stimulus device. The phrase “somatosensory stimulation epochs” does not refer back to the previously recited “somatosensory stimuli” in claim 1. As such, the “somatosensory stimulation epochs” could be any somatosensory stimulation epochs, including during “incidental oral activity during feeding”.
Applicant’s argument that O’Reilly teaches away from adopting Inder’s SEF analysis is not persuasive. Inder was not used to modify O’Reilly so that SEF measurements are analyzed to determine an index of brain maturation. Instead, Inder was used to modify O’Reilly so that SEF measurements are analyzed to define the presence and severity of white matter injury in preterm infants.
Applicant’s argument that the combination of references improperly modifies the principal of operation of O’Reilly is not persuasive. Applicant appears to be arguing that it would be improper to modify O’Reilly to include analyzing SEF information and to include a controlled somatosensory stimulus device that delivers treatment because this would change “O’Reilly’s approach from passive developmental monitoring using amplitude-based indices to active evoked-response characterization using spectral frequency analysis”. This is not a persuasive argument. First, the claimed invention does not require amplitude-based indices to be monitored. Claims 2, 3, 8, 9, 13, 14, 17, and 18 make clear, by virtue of the phrase “or a combination thereof” (emphasis added), that the amplitude-based metrics are an option, not a requirement. Second, the SEF measurement analysis taught by Inder is not a replacement for the amplitude-based metrics analysis taught by O’Reilly. O’Reilly teaches analyzing amplitude-based metrics to determine brain maturation, and Inder teaches analyzing SEF measurements to determine the presence and severity of white matter injury. In the combination of O’Reilly in view of Inder further in view of Bell further in view of Barlow, both amplitude-based metrics and SEF measurements are analyzed – one to determine brain maturation, and the other to determine the presence and severity of white matter injury. It is further noted that neither claim 1 nor claim 12 require determining an index or measure of brain maturation/development.
Regarding the “develop” limitation of claim 1, the Examiner provides the following explanation of why the cited prior art reads on the claimed “develop” limitation:
The system of O’Reilly in view of Inder further in view of Bell further in view of Barlow receives EEG data from one or more electrodes while a pre-term infant is feeding (as taught by O’Reilly), generates SEF information from the EEG data (motivation provided by Inder), wherein the EEG data characterizes thalamocortical excitation evoked by synchronous volleys of oral mechanoreceptive afferent activity of a trigeminal nerve, develops a treatment plan based on the spectral information received while the pre-term infant is feeding (motivation provided by Bell), wherein the treatment plan includes one or more entrainment procedures implemented by a NNS entrainment system that entrains electrophysiological development in a brain of the pre-term infant (motivation provided by Barlow), and generates one or more control signals to a somatosensory stimulus device to provide somatosensory stimuli to the patient based on the developed treatment plan (motivation provided by Barlow), thus providing therapeutic stimulus to the pre-term infant via additional somatosensory stimuli. Regarding claim 12, it is noted that the steps recited in a method claim need not be performed in the order in which they appear in the method claim unless the claim specifically recites in which order the steps are performed.
The remainder of the Applicant’s arguments have been addressed by the arguments provided above, and will not be further addressed.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure:
Bell et al. (Spectral Edge Frequency of the EEG…) teaches that SEF is a useful measure of cerebral maturation in the newborn.
Szeto (Spectral Edge Frequency as a Simple Quantitative…) teaches using spectral edge frequency as a measure of the maturation of electrocortical activity.
Niemarkt et al. (Quantitative Analysis of Amplitude-Integrated…) teaches analyzing aEEG to monitor cerebral activity in preterm infants.
Slattery et al. (Early sucking and swallowing problems…) teaches that early sucking and swallowing problems may be potential markers of neonatal brain injury.
West et al. (Quantitative electroencephalographic patterns…) teaches determining changes in SEF measurements in preterm infants.
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/ETSUB D BERHANU/Primary Examiner, Art Unit 3791
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